CTRI/2019/04/018826已完成2 期
Preclinical and Clinical Evaluation of Gomutradi Kshara in the Management of Medoroga With Special Reference to Dyslipidaemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients between the age group of 18-60 years of either sex.
- •2. Diagnosed & confirmed cases of Dyslipidaemia ( Medoroga) on the basis of criteria given by NCEP-ATPIII. (If any one of the following)
- •a) Serum Cholesterol >= 200 mg/dl
- •b) Serum Triglycerides >= 150 mg/dl
- •c) LDL Cholesterol >= 130 mg/dl
- •d) HDL Cholesterol < 40 mg/dl
- •3. Willing and able to participate in the study for 1 months.
排除标准
- •1. Patients having medical history of-
- •a) Unstable angina
- •b) Patients who have a past history of Atrial
- •Fibrillation, Acute Coronary Syndrome,
- •Myocardial Infarction, Stroke or severe
- •Arrhythmia in the last six months.
- •c) Patients on prolonged ( > 6 weeks)
- •medication with corticosteroids,
- •antidepressants, anticholinergics,
- •immunosuppressants, oestrogen replacement
- •therapy etc. or any other drugs that may have
- •an influence on the outcome of the study.
- •d) Symptomatic patient with clinical evidence
- •of Heart failure.
- •e) Patients with poorly controlled hypertension
- •(systolic >160 and diastolic >100 mm of Hg)
- •f) Uncontrolled Diabetes Mellitus.
- •g) Impaired Renal function (Creatinine >2mg/dl).
- •h) ALT and AST > 2 times of upper limit of
- •normal (40 mg/dl).
- •i) Hypothyroidism.
- •j) Patients with evidence of malignancy.
- •k) Patients on oral contraceptives.
- •l) Alcoholics and /or drug abusers.
- •m) Hypersensitivity to any of the trial drugs
- •or their ingredients.
- •n) Patients who have completed participation in
- •any other clinical trial drugs or their
- •ingredients.
- •o) Patients who have received any cholesterol
- •lowering medication (Modern Drug within last
- •2. Pregnancy, Lactation and patients having
- •Dyslipidaemia due to drugs e.g.
- •Glucocorticoids ,Diuretics etc.
研究者
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